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A Study to Assess Change in Disease Activity and Adverse Events in Adult Participants With Gynecologic Cancers Receiving Intravenous Infusion of IMGN151 as Monotherapy or in Combination With Other Therapies

RecruitingPhase 2Ages 18 Years - anyFemaleAbbVie
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In plain words

What the trial is, and whether it could suit you

Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety and tolerability of IMGN151 when given as monotherapy and in combination with other anti-cancer therapies in adult participants with gynecologic cancers. IMGN151 is an investigational drug being developed for the treatment of gynecologic cancers. Participants are placed in 1 of 4 groups, called treatment arms. Each group receives a different treatment. Around 377 participants with gynecologic cancers will be enrolled in the study at approximately 50 sites worldwide. Participants will receive intravenous infusions of IMGN151 as monotherapy or in combination with anti-cancer therapies according to their assigned study arm. In Arm A, participants will receive IMGN151 in combination with carboplatin on Day 1 of each cycle. In Arm B, participants will

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * ECOG performance status of 0 or 1 * Participants (except for platinum-sensitive ovarian, fallopian tube, and primary peritoneal cancer (PSOC) participants without disease progression after platinum combination standard of care therapy in Arms B and D) will have โ‰ฅ 1 lesion that meets the definition of measurable disease by RECIST v1.1 (radiographically measured by the investigator). * Participants will have high-grade serous epithelial ovarian, fallopian tube, and primary peritoneal cancers (EOC). * Participant has completed prior therapy within the specified times below: * Systemic antineoplastic therapy within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose of IMGN151. * Focal radiation completed โ‰ฅ 2 weeks prior to the first dose of study treatment. Exclusion Criteria: * Participants with ovarian cancer with histologies including: endometrioid, clear cell, mucinous, or sarcomatous histology, mixed tumors containing any of the above histologies, as well a low-grade or borderline ovarian tumor. * History of clinically significant medical conditions or any other reason that the investigator determines would interfere with the participant's participation in this study or would make the participant an unsuitable candidate to receive study treatment. * Prior treatment with FRฮฑ-targeting therapy. * Prior wide-field radiotherapy affecting more than 20% of the bone marrow.
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What it tests

  • IMGN151
  • Carboplatin
  • Bevacizumab
  • Olaparib
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Where

21 sites
Start Los Angeles /ID# 281533
Los Angeles, United States
University of Colorado Hospital- Aurora /ID# 278232
Aurora, United States
University Of Minnesota /ID# 277850
Minneapolis, United States
Holy Name Medical Center /ID# 279017
Teaneck, United States
SUNY Upstate Medical University - Syracuse /ID# 277305
Syracuse, United States
University of Cincinnati Medical Center. /ID# 278925
Cincinnati, United States
University Hospitals Cleveland Medical Center /ID# 279601
Cleveland, United States
OU Health - Stephenson Cancer Center /ID# 277656
Oklahoma City, United States

โ€ฆand 13 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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